Device product
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Z-0669-2025
Product summary
- Firm
- Hologic, Inc
- Event
- Event 95781
- Status
- Completed
- Classification
- Class II
- Quantity
- 178 units
- Official record key
device-enforcement:Z-0669-2025
Official wording
Reason: IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
Code information: Model No F0101. UDI 15420045515390. Lot Numbers: 186728, SS1-200727, SS1-181121, SS1-190301, SS1-190501, 175517, 175516, 162427, 140718-01, 171056, 175515.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set